G60511.mp4

In 2022, Atrium Medical initiated a for certain units due to concerns regarding the balloon or catheter hub separating during removal. This issue was most frequently observed when the device was used "off-label" for vascular conditions before it received official FDA approval for that specific use. Important Usage Precautions

the stent beyond recommended diameters, as this can lead to stent fracture. g60511.mp4

As of March 2024, Cook Medical entered an exclusive agreement with Getinge to distribute the iCast system in the United States. Safety and Recalls In 2022, Atrium Medical initiated a for certain

The iCARUS clinical trial demonstrated a 96.4% primary patency rate at 9 months, showing the device is highly effective for vascular treatment. g60511.mp4

FDA MedWatch - iCast Covered Stent by Atrium Medical: - GovDelivery